Incontinence device

ABSTRACT

An incontinence device is used to apply supporting pressure to an anterior wall of an inferior third of a vaginal canal in the approximate plane of a pubococcygeal muscle and ultimately to a urethra for controlling incontinence. The incontinence device includes a first member having a first end and second end, as well as a second member resiliently connected to the first member. The second member is biased outwardly from the first member to direct the first end of the first member toward the anterior wall of the vaginal canal in a manner providing a support structure transferring upward force for support of the urethra by the first end of the first member.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Patent Application Ser. No.62/366,471, entitled “STRESS INCONTINENCE DEVICE,” filed Jul. 25, 2016.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention generally relates to an incontinence device.

2. Description of the Related Art

By way of background, it is well appreciated the female pelvic regionincludes portions of the female reproductive system, femalegastrointestinal system and the female urinary system. The female pelvicregion is shown in FIGS. 1 and 2, and includes a vagina 200, a cervix210, a uterus 212, a urethra 208, a bladder 214 and a symphysis pubis216. The vagina 200 includes an introital opening 218 that exits thehuman body and contains a vaginal canal 202 extending from the introitalopening 218 to the cervix 210. The vaginal canal 202 has a length thatranges from between about 4 to about 6 inches in most women. The cervix210 is the entrance to the uterus and is located between the upperaspect of the vaginal canal 202 and the uterus 212. The vaginal canal202 has an inner periphery 220.

The inner periphery 220 of the vaginal canal is composed of a rightlateral wall 222, a left lateral wall (not shown), an anterior wall 206,and a posterior wall 204. The four walls encompass the entire 360degrees of the inner periphery 220. The anterior wall 206 is locatedclosest to the urethra 208 and the urethra 208 is located between thesymphysis pubis 216 and the vagina 200.

The vaginal canal 202 is commonly divided into three approximately equalsections, that is, the inferior third 236, the middle third 237 and thesuperior third 238, each representing about one-third of the overalllength. Each section is approximately 2 inches in length. The inferiorthird 236 of the vaginal canal 202 is the most important section foralleviating female urinary incontinence because of its proximity to theurethra 208. The inferior third 236 of the vaginal canal 202 is thelocation affected by placement of vaginal insert devices which alleviateconditions of female incontinence, regardless of where in the vagina 202the bulk of the device rests after insertion. In the erect female, themiddle third 237 of the vaginal canal 202 is horizontally offset fromthe inferior third 236 of the vaginal canal 202 which is substantiallyparallel to the urethra 208. The urethra 208 is situated between theinferior third 236 of the vaginal canal 202 and the symphysis pubis 216,which is a bony structure situated adjacent to a front portion of thehuman torso and may be referred to as the bladder neck region.

The urethra 208, also referred to as a urethral tube, is a hollowtubular structure positioned anterior to the vaginal canal 202. Theurethra 208 extends from a first opening 226 that exits the human bodyto a second opening 228 situated at the lower surface of the bladder214. The posterior urethrovesical angle is formed where the urethra 208enters the bladder 214. The urethra 208 has a length of about 1.5 inchesin most women. The urethra 208 functions to discharge urine, which istemporarily stored in the bladder 214, from the human body. The urethra208 has a plurality of urethral sphincter muscles 232 located along thelength of its inner periphery. The urethral sphincter muscles 232 aresituated below the opening 228 and are ring like muscles that normallymaintain constriction of the urethra 208 to prevent the passage ofurine. The relaxation of the urethral sphincter muscles 232 by normalphysiological functioning will permit urine to be voluntarily expelledfrom the body.

The pubococcygeal muscle 233 originates at the symphysis pubis 216 andextends to the inferior extent of the coccyx 234 with a passage in thecenter of the muscle through which the rectum 235, vagina 200 andurethra 208 pass. The posterior portion of the passage through thepubococcygeal muscle 233 normally provides support to the posteriorportion of the urethra 208 through the soft tissues of the rectum 235and vagina 200 which assist in maintaining constriction of the urethra208 to prevent the passage of urine. When the pubococcygeal muscle 233stretches due to childbirth or generally relaxes due to the normal agingprocess, support to the posterior portion of the urethra 208 is reducedand unintentional flow of urine through the urethra 208 may occur,particularly when pressure is applied to the bladder 214 during a coughor other abdominal contraction. This condition is known as stressincontinence. Replacing or supplementing support to the posterior sideof the urethra 208 can help to prevent the unintentional flow of urinethrough the urethra 208.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide anincontinence device used to apply supporting pressure to an anteriorwall of an inferior third of a vaginal canal in the approximate plane ofa pubococcygeal muscle and ultimately to a urethra for controllingincontinence. The incontinence device includes a first member having afirst end and second end, as well as a second member resilientlyconnected to the first member. The second member is biased outwardlyfrom the first member to direct the first end of the first member towardthe anterior wall of the vaginal canal in a manner providing a supportstructure transferring upward force for support of the urethra by thefirst end of the first member.

It is also an object of the present invention to provide an incontinencedevice wherein the incontinence device is constructed of a flexible,biocompatible polymeric or elastomeric material.

It is another object of the present invention to provide an incontinencedevice wherein the first member is shaped and dimensioned forpositioning upon either a posterior wall or an anterior wall of thevaginal canal.

It is a further object of the present invention to provide anincontinence device wherein the first member is substantially flat alongits upper and lower surfaces such that the upper surface lies in a firstplane and the lower surface lies in a second plane that is substantiallyparallel to the first plane.

It is also an object of the present invention to provide an incontinencedevice wherein the first member includes a first ring element at thefirst end of the first member and a second ring element at the secondend of the first member, wherein the first ring element and the secondring element share a segment at a junction of the first ring element andthe second ring element.

It is another object of the present invention to provide an incontinencedevice wherein the second member is constructed as a ring.

It is a further object of the present invention to provide anincontinence device wherein the second member has a diameter that isslightly smaller than that of the first ring element such that thesecond member fits within the first ring element of the first memberwhen the incontinence device is compressed to a low profile deploymentconfiguration.

It is also an object of the present invention to provide an incontinencedevice wherein the second member is secured to the first member at thejunction of the first and second ring elements of the first member in amanner allowing the second member to pivot relative to the first member.

It is another object of the present invention to provide an incontinencedevice wherein the first ring element is larger than the second ringelement.

It is a further object of the present invention to provide anincontinence device wherein the second ring element of the first memberis provided with a pressure application member at a positiondiametrically opposed to the junction of the first and the second ringelements of the first member, wherein the pressure application member isshaped and dimensioned to provide support to the urethra at the firstend of the first member.

It is also an object of the present invention to provide an incontinencedevice wherein the pressure application member includes a wedgeconfiguration with a bottom surface extending at an angle from a lowersurface of the second ring element of the first member and a top surfaceextending at an angle from an upper surface of the second ring elementof the first member to a tip of the wedge.

It is another object of the present invention to provide an incontinencedevice wherein a pressure application member is provided at the firstend of the first member, the pressure application member being shapedand dimensioned to provide support to the urethra at the first end ofthe first member.

It is a further object of the present invention to provide anincontinence device wherein the pressure application member issymmetrical allowing for either side thereof to provide support to theurethra.

It is also an object of the present invention to provide an incontinencedevice including a removal string attached to the incontinence devicefirst member.

It is also an object of the present invention to provide an incontinencedevice wherein the removal string is attached to the first member.

Other objects and advantages of the present invention will becomeapparent from the following detailed description when viewed inconjunction with the accompanying drawings, which set forth certainembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a cross section view of the female pelvic region with the presentincontinence device inserted with the lower surface of the large firstring element facing the posterior wall of the vaginal canal.

FIG. 2 a cross section view of the female pelvic region with the presentincontinence device inserted with the lower surface of the first memberfacing the anterior wall of the vaginal canal.

FIG. 3 is a perspective view of the incontinence device.

FIG. 4 is a top plan view of the incontinence device shown in FIG. 3.

FIG. 5 is a side elevation view of the incontinence device shown in FIG.3, which shows in broken lines the second member ring recessed withinthe first ring member.

FIG. 6 is a perspective view of an alternative embodiment of anincontinence device.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The detailed embodiment of the present invention is disclosed herein. Itshould be understood, however, that the disclosed embodiment is merelyexemplary of the invention, which may be embodied in various forms.Therefore, the details disclosed herein are not to be interpreted aslimiting, but merely as a basis for teaching one skilled in the art howto make and/or use the invention.

Referring to FIGS. 1 to 5, and considering the female pelvic anatomy asdescribed above with reference to FIGS. 1 and 2, the present stressincontinence device 10 is adapted for positioning such that the firstend 16 rests in the plane of pubococcygeal muscle 233 with the remainderof the stress incontinence device 10 in central and superior portions ofvaginal canal 202. The stress incontinence device 10 is positioned suchthat the pressure application member 48 at the first end 16 of thestress incontinence device can be used to apply pressure support to theanterior wall 206 of the inferior third 236 of the vaginal canal 202 inthe approximate plane of the pubococcygeal muscle 233 and ultimately tothe urethra 208 for controlling incontinence. As will be discussed belowin greater detail, the incontinence device 10 may be positioned withinthe vaginal canal with either the large first ring element 26 of thefirst member 12 is supported upon the posterior wall 204 of the vaginalcanal 202 or the large first ring element 26 of the first member issupported upon the anterior wall 206 of the vaginal canal 202; as such,the stress incontinence device 10 may be insert upside down.

The incontinence device 10 is constructed of a material that is flexiblein nature, such as a heavy silicone, so that the stress incontinencedevice 10 can collapse inside an applicator. It is further contemplatedthe stress incontinence device 10 may be composed of other flexible,biocompatible polymeric or elastomeric materials such as polyolefins,acetel, urethane, ABS, or various thermoplastic elastomers.

The stress incontinence device 10 includes a first member 12 and asecond member 14 resiliently connected in a manner providing a supportstructure transferring upward force for support of the urethra 208 bythe first end 20 of the first member 12. The stress incontinence device10 includes a first end 16 and a second end 18. As will be appreciatedbased upon the following disclosure, the first member 12 of the stressincontinence device 10 is shaped and dimensioned for positioning uponeither the posterior wall 204 or the anterior wall 206 of the vaginalcanal 202, while the second member 14 is biased outwardly from the firstmember 12 in a manner causing contact with the opposite wall of thevaginal canal 202 to direct the first end 16 of the stress incontinencedevice 10, in particular, the first end 20 of the first member 12 towardthe anterior wall 206 of the vaginal canal 202 and ultimately intocontact with the urethra 208 for controlling incontinence.

The first member 12 is substantially flat along its upper and lowersurfaces 22, 24 such that the upper surface 22 lies in a first plane andthe lower surface 24 lies in a second plane that is substantiallyparallel to the first plane. With this in mind, it is appreciated thelower surfaces 25, 42 of the first and second ring elements 26, 28 areslightly offset such that the lower surface 42 of the small second ringelement 28 sits slightly above the lower surface 25 of the large firstring element 26. It is appreciated relative terms such as upper, lower,top and bottom are used throughout the present disclosed, and theseterms are merely used in reference to the various drawings employed indisclosing the present invention.

The first member 12 is composed of a large first ring element 26 and asmall second ring element 28. The first and second ring elements 26, 28used in the construction of the stress incontinence device 10 are shapedand dimensioned to optimize support of the first member 12, inparticular, support of the large first ring element 26, along theposterior wall 204 or anterior wall 206 of the vaginal canal 202 in amanner allowing the small second ring element 28 at the first end 20 ofthe first member 12 to engage, and apply force to, the anterior wall 206of the vaginal canal 202 for controlling incontinence.

With this in mind, the first member 12 includes a first end 20 at whichthe small second ring element 28 is positioned and a second end 30 atwhich the large first ring element 26 is positioned. The small secondring element 28 and the large first ring element 26 are joined at ajunction 32 where the large first ring element 26 continues itscircumference and the small second ring element 28 includes a smallinward section, that is, the small second ring element 28 and the largefirst ring element 26 share an arcuate segment 34 at the junction 32,wherein the arcuate segment 34 is continuous with the large first ringelement 26.

The large first ring element 26 includes an upper surface 22, a lowersurface 24, an outer side wall 36 between the upper and lower surfaces23, 25, and an inner side wall 38 between the upper and lower surfaces23, 25. Similarly, the small second ring element 28 includes an uppersurface 40, a lower surface 42, an outer side wall 44 between the upperand lower surfaces 40, 42, and an inner side wall 46 between the upperand lower surfaces 40, 42.

The small second ring element 28 is further provided with a pressureapplication member 48 at a position diametrically opposed to thejunction 32 of the small second ring element 28 and the large first ringelement 26. The pressure application member 48 is shaped and dimensionedto provide support to the urethra 208 at the first end 16 of the stressincontinence device 10. As such, the pressure application member 48includes a wedge configuration with a bottom surface 50 extending at anangle from the lower surface 42 of the small second ring element 28 anda top surface 52 extending at an angle from the upper surface 40 of thesmall second ring element 28 to the tip 53 of the wedge to form anisosceles triangular configuration. While a wedge shape is disclosedabove for the pressure application member it is contemplated thepressure application member could be more bulbous and/or rounded. Inaddition to the application of pressure, the small second ring element28 acts as a secondary manual loop for removal, should string removalfail.

The pressure application member 48, in particular, the bottom and topsurfaces 50, 52 are angled so that the flat of the “blade” defined bythe pressure application member provides the support to the urethra 208(that is, the top surface 52 of the pressure application member 48 whenthe large first ring element 26 is supported upon the posterior wall 204of the vaginal canal 202 or the bottom surface 50 of the pressureapplication member 48 when the large first ring element 26 is supportedupon the anterior wall 206 of the vaginal canal 202) as the pressureapplication member 48 is brought into contact with the anterior wall 206of the vaginal canal 202 and applies pressure to the urethra 202 (seeFIGS. 1 and 2). As such, the pressure application member 48 issubstantially symmetrical. In particular, the top surface 52 comes intocontact with the anterior wall 206 of the vaginal canal 202 to providesupport to the urethra 208 when the large first ring element 26 issupported upon the posterior wall 204 of the vaginal canal 202, and thebottom surface 50 of the pressure application member 48 comes intocontact with the anterior wall 206 of the vaginal canal 202 to providesupport to the urethra 208 when the large first ring element 26 issupported upon the anterior wall 206 of the vaginal canal 202 (see FIGS.1 and 2).

In accordance with an alternate embodiment shown in FIG. 6, the smallsecond ring element 28 takes a shape that is not completely circular,but rather includes an arcuate front end adjacent to the pressureapplication member and straightening side walls that are ultimatelycoupled with the large first ring element at the junction in a mannersimilar to the embodiment disclosed above. With this in mind, and inaccordance with this embodiment, the small second ring element includesan upper surface 40, a lower surface 42, an outer side wall 44 betweenthe upper and lower surfaces 40, 42, and an inner side wall 46 betweenthe upper and lower surfaces 40, 42. The small second ring element 28 isfurther provided with a pressure application member 48 at a positiondiametrically opposed to the junction 32 of the small second ringelement 28 and the large first ring element 26.

As with the prior embodiment, the pressure application member 48 isshaped and dimensioned to provide support to the urethra 208 at thefirst end 16 of the stress incontinence device 10. The pressureapplication member 48 includes a wedge configuration with a bottomsurface 50 extending at an angle from the lower surface 42 of the smallsecond ring element 28 and a top surface 52 extending at an angle fromthe upper surface 40 of the small second ring element 28 to the tip 53of the wedge to form an isosceles triangular configuration. In contrastto the embodiment disclosed with reference to FIGS. 1 to 5, the pressureapplication member 48 of the this embodiment is integrated with theremainder of the small second ring element 28 such that there is nodistinct transition. Rather, the small second ring element 28 includes asmooth exterior surface. While a wedge shape is disclosed above for thepressure application member it is contemplated the pressure applicationmember could be more bulbous and/or rounded.

A string removal loop 29 is also provided within the small second ringelement 28. The sting removal loop 29 is shaped and dimensioned forattachment of the removal string 15 thereto and is formed along thejunction so as to extend into the interior space defined by the smallsecond ring element 28. In addition to the application of pressure, thesmall second ring element 28 acts as a secondary manual loop forremoval, should removal string 15 fail.

As with the embodiment disclosed above with reference to FIGS. 3 to 5,the pressure application member 48, in particular, the bottom and topsurfaces 50, 52 are angled so that the flat of the “blade” defined bythe pressure application member provides the support to the urethra 208as the pressure application member 48 is brought into contact with theanterior wall 206 of the vaginal canal 202 and applies pressure to theurethra 202.

The second member 14 is also constructed as a ring. As with the firstand second ring elements 26, 28, the second member ring 54 includes anupper surface 56, a lower surface 58, an outer side wall 60 between theupper and lower surfaces 56, 58, and an inner side wall 62 between theupper and lower surfaces 56, 58. The second member ring 54 has adiameter that is slightly smaller than that of the large first ringelement 26 such that the second member ring 54 fits within the largefirst ring element 26 when the stress incontinence device 10 iscompressed to its low profile deployment configuration. The secondmember ring 54 is secured to the first member 12 at the junction 32 ofthe first and second ring elements 26, 28 in a manner allowing thesecond member ring 54 to pivot relative to the first member 12. Thesecond member ring 54 is aligned to pivot relative to the large firstring element 26 of the first member 12 such that the second member ring54 pivots about an axis that extends transvers to the arcuate segment 34at the junction 32 of the large first ring element 26 and the smallsecond ring element 28. With this arrangement, and if one where to pivotthe second member ring 54 about the axis it would fits within the largefirst ring element 26. This ability to recess the second member ring 54within the first ring element 26 provides for a substantially profilereduction and thereby assists in deployment and removal. It isappreciated that while the second member ring 54 is disclosed herein asbeing slightly smaller than the large first ring element 26, the sizescould be flipped without departing from the spirit of the presentinvention, that is, the first ring element 26 could be made to have asmaller diameter so that it fits within second member ring 54.

As mentioned above, the stress incontinence device 10 is constructed toallow for movement of the second member 14, that is, the second memberring 54, relative to the first member 12, that is, the large first ringelement 26 and the small second ring element 28. The movement occurs asa result of a resilient bias created at the junction of the secondmember ring 54 and the second member 14 which biases the second memberring 54 in a direction away from the large first ring element 26. Inaccordance with a preferred embodiment, the positioning of the largefirst ring element 26 and the second member ring 54 in their fullyexpanded orientation is such that that they are set at a physiologicallyappropriate angle (34-44 degrees, depending on flexion capabilities). Inparticular, the bias causes the portion of the second member ring 54diametrically opposed to the junction 64 of the second member ring 54and the second member 14 to move away from the portion of the largefirst ring element 26 diametrically opposed to the junction 64 of thesecond member ring 54 and the second member 14 in a manner allowing thecontrolled expansion of the stress incontinence device 10 that forcesthe pressure application member 48 toward the anterior wall 206 of thevaginal canal 202 when the stress incontinence device 10 is properlypositioned within the vaginal canal 202 to apply pressure to theanterior wall 206 of the vaginal canal 202 and ultimately to the urethra208 for controlling incontinence.

In practice, the stress incontinence device 10 is prepackaged within aninserter for deployment within the vaginal canal 202. Although not shownit is contemplated an inserter would simply be a “tubular structure” inwhich the stress incontinence device 10 is drawn into a pre-collapsedorientation to ease initial placement into the vagina. It would then,however, need to be “pushed out” of the tube to remain in the vagina.

While in the inserter the second member 14 is collapsed into the firstmember 12 so as to reduce the profile of the stress incontinence device10 and ease insertion within the vaginal canal (that is, the insertionstate of the stress incontinence device 10). The stress incontinencedevice 10 is then inserted within the vaginal canal 202 and positionedwith the lower surface of the first member 12 in contact with theposterior wall 204 of the vaginal canal 202. In particular, the stressincontinence device 10 is inserted into the vagina 200 with the largefirst ring element 26 and the second member ring 54 on the second end 18of the stress incontinence device 10 entering the vagina 200 first. Thesmall second ring element 28 and pressure application member 48 on thefirst end 16 of the stress incontinence device 10 enters the vagina 200last. The large first ring element 26 and the second member ring 54,which compress during entry, into the vagina expand in the deep portionof the vagina 200 which, in the erect female, is above but generallyparallel to the muscles in the pelvic floor. This maintains the devicein the vagina 200.

The pressure application member 48 of the stress incontinence device 10then rests in the deep portion of the vagina 200. The vagina 200 of theerect female bends inferiorly and in an anterior direction, passingthrough the muscles of the pelvic floor. The small second ring element28 and pressure application member 48 on the first end 16 of the stressincontinence device 10 rest in this part of the vagina 200 such that thesupport feature falls in the plane of the pelvic floor muscles.

Once the stress incontinence device 10 is properly positioned within thevaginal canal 202, the second member 14 is releases allowing the secondmember ring 54 to move outwardly away from the large first ring element26. It is appreciated, the small second ring element 28 at the first end16 of the stress incontinence device 10 flairs and provides positivepositioning support around the opening in the pelvic floor opposite ofthe large first ring element 26 and the second member ring 54 to helpsecure the stress incontinence device 10 in place.

The movement of the second member ring 54 away from the large first ringelement 26 causes the pressure application member 48 at the first end 20of the first member 12 to move into contact with the anterior wall 206of the vaginal canal 202 in a manner applying pressure thereto thatultimately applies pressure to the urethra 208 for controllingincontinence. Cooperation between a stress incontinence device 10positioned in the vagina 200 and the symphysis pubis 216 allows theurethra 208 to be compressed upon itself thereby providing a means toalleviate involuntary urine flow from the bladder.

When deployed with the lower surface 25 of the large first ring element26 supported upon the posterior wall 204 of the vaginal canal as shownin FIG. 1, the top surface 52 of the pressure application member 48places a supporting force on the posterior wall 204 of the urethra 208in a direction that is substantially perpendicular to the lumen of theurethra 208. This support emulates the natural support of the pelvicfloor muscles which prevents unintended relief of the bladder throughthe urethra in normal, healthy physiological conditions.

In particular, the positioning of the large first ring element 26 andthe second member ring 54 in their fully expanded orientation (that is,the deployed state of the stress incontinence device 10) is such thatthat they are set at a physiologically appropriate angle (34-44 degrees,depending on flexion capabilities) to cause the desired interior withthe anterior wall and the urethra 208. The large first ring element 26and the second member ring 54, in conjunction with the opening in thepelvic floor, provide the support structuring and transfer upward forcefor the urethral support to the first end 20 of the first member 12 atthe first end 16 of the stress incontinence device 10. This interactionwith the posterior wall 204 of the vaginal canal 202 creates the supportbase and force transfer for urethral support. The function of the stressincontinence device 10 is based on the concept that support of thepelvic floor muscles posterior to the urethra 208 in normal, healthyphysiological conditions prevents unintended relief of the bladderthrough the urethra.

It is appreciated that it is not necessary to position the lower surface24 of the first member 12 (in particular, the lower surface 25 of thelarge first ring 26) in contact with the posterior wall 204 of thevaginal canal 202, but the lower surface 24 of the first member 12 maybe positioned in contact with the anterior wall 206 of the vaginal canal202 as shown in FIG. 1. In such an arrangement, bottom surface 50 of thepressure application member 48 comes into contact with the anterior wall206 of the vaginal canal 202 to provide support to the urethra 208 whenthe lower surfaces 25, 42 of both the large first ring 26 and the smallsecond ring element 28 are also supported upon the anterior wall 206 ofthe vaginal canal 202.

In particular, and as with the previously described deploymentorientation, the stress incontinence device 10 is inserted into thevagina 200 with the large first ring element 26 and the second memberring 54 on the second end 18 of the stress incontinence device 10entering the vagina 200 first. The small second ring element 28 andpressure application member 48 on the first end 16 of the stressincontinence device 10 enters the vagina 200 last. The pressureapplication member 48 of the stress incontinence device 10 then rests inthe deep portion of the vagina 200. In contrast to the embodimentdisclosed with reference to FIG. 1, the lower surface 24 of the firstmember 12 (that is, the lower surfaces 25, 42 of both the large firstring element 26 and small second ring element 28) faces the anteriorwall 206 of the vaginal canal 202.

Once the stress incontinence device 10 is properly positioned within thevaginal canal 202, the second member 14 is released allowing the secondmember ring 54 to move outwardly away from the large first ring element26. It is appreciated, the small second ring element 28 at the first end16 of the stress incontinence device 10 flairs and provides positivepositioning support around the opening in the pelvic floor opposite ofthe large first ring element 26 and the second member ring 54 to helpsecure the stress incontinence device 10 in place. The second memberring 54 moves away from the large first ring element 26 until the topsurface of the second ring member 54 comes into contact with theposterior wall 204 of the vaginal canal 202, which in turn causes thepressure application member 48 at the first end 20 of the first member12 to move toward the anterior wall 206 of the vaginal canal 202 in amanner applying pressure thereto that ultimately applies pressure to theurethra 208 for controlling incontinence. Cooperation between a stressincontinence device 10 positioned in the vagina 200 and the symphysispubis 216 allows the urethra 208 to be compressed upon itself therebyproviding a means to alleviate involuntary urine flow from the bladder.The bottom surface 50 of the pressure application member 48 places asupporting force on the posterior side of the urethra 208 in a directionthat is substantially perpendicular to the lumen of the urethra 208.This support emulates the natural support of the pelvic floor muscleswhich prevents unintended relief of the bladder through the urethra 208in normal, healthy physiological conditions. The large first ringelement 26 and the second member ring 54, in conjunction with theopening in the pelvic floor, provide the support structuring andtransfer upward force for the urethral support to the first end 20 ofthe first member 12 at the first end 16 of the stress incontinencedevice 10. This interaction with the posterior wall 204 of the vaginalcanal 202 creates the support base and force transfer for urethralsupport.

Ultimately, the function of the stress incontinence device 10 is basedon the concept that support of the pelvic floor muscles posterior to theurethra 208 in normal, healthy physiological conditions preventsunintended relief of the bladder through the urethra.

When it is desired to remove the stress incontinence device 10, thehuman user may simply pull upon the removal string 15. Pulling upon theremoval string 15 causes the stress incontinence device 10 to movetoward the introital opening 218 and out of the vaginal canal 202. As aresult of the shape of the vaginal canal 202 and the introital opening218, the first and second members 12, 14 move toward each other, thatis, the second member ring 54 moves toward the large first ring element26 an ultimately resembles the insertion state discussed above as it isfinally pulled through the introital opening 218 and out of the vagina200.

While the preferred embodiments have been shown and described, it willbe understood that there is no intent to limit the invention by suchdisclosure, but rather, it is intended to cover all modifications andalternate constructions falling within the spirit and scope of theinvention.

1. An incontinence device used to apply supporting pressure to an anterior wall of an inferior third of a vaginal canal in the approximate plane of a pubococcygeal muscle and ultimately to a urethra for controlling incontinence, comprising: a first member having a first end and second end; a second member resiliently connected to the first member, and the second member is biased outwardly from the first member to direct the first end of the first member toward the anterior wall of the vaginal canal in a manner providing a support structure transferring upward force for support of the urethra by the first end of the first member.
 2. The incontinence device according to claim 1, wherein the incontinence device is constructed of a flexible, biocompatible polymeric or elastomeric material.
 3. The incontinence device according to claim 1, wherein the first member is shaped and dimensioned for positioning upon either a posterior wall or an anterior wall of the vaginal canal.
 4. The incontinence device according to claim 1, wherein the first member is substantially flat along its upper and lower surfaces such that the upper surface lies in a first plane and the lower surface lies in a second plane that is substantially parallel to the first plane.
 5. The incontinence device according to claim 1, wherein the first member includes a first ring element at the first end of the first member and a second ring element at the second end of the first member, wherein the first ring element and the second ring element share a segment at a junction of the first ring element and the second ring element.
 6. The incontinence device according to claim 5, wherein the second member is constructed as a ring.
 7. The incontinence device according to claim 6, wherein the second member has a diameter that is slightly smaller than that of the first ring element such that the second member fits within the first ring element of the first member when the incontinence device is compressed to a low profile deployment configuration.
 8. The incontinence device according to claim 7, wherein the second member is secured to the first member at the junction of the first and second ring elements of the first member in a manner allowing the second member to pivot relative to the first member.
 9. The incontinence device according to claim 5, wherein the second member is secured to the first member at the junction of the first and second ring elements of the first member in a manner allowing the second member to pivot relative to the first member.
 10. The incontinence device according to claim 5, wherein the first ring element is larger than the second ring element.
 11. The incontinence device according to claim 5, wherein the second ring element of the first member is provided with a pressure application member at a position diametrically opposed to the junction of the first and the second ring elements of the first member, wherein the pressure application member is shaped and dimensioned to provide support to the urethra at the first end of the first member.
 12. The incontinence device according to claim 11, wherein the pressure application member includes a wedge configuration with a bottom surface extending at an angle from a lower surface of the second ring element of the first member and a top surface extending at an angle from an upper surface of the second ring element of the first member to a tip of the wedge.
 13. The incontinence device according to claim 1, wherein a pressure application member is provided at the first end of the first member, the pressure application member being shaped and dimensioned to provide support to the urethra at the first end of the first member.
 14. The incontinence device according to claim 13, wherein the pressure application member is symmetrical allowing for either side thereof to provide support to the urethra.
 15. The incontinence device according to claim 13, wherein the pressure application member includes a wedge configuration with a bottom surface extending at an angle from a lower surface of the second ring element of the first member and a top surface extending at an angle from an upper surface of the second ring element of the first member to a tip of the wedge.
 16. The incontinence device according to claim 1, further including a removal string attached to the incontinence device first member.
 17. The incontinence device according to claim 16, wherein the removal string is attached to the first member. 